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FDA 510(k)

NobelZygoma 45°

K-Number: K152093 · 2016-03-16

ApplicantNobel Biocare AB
Decision Date2016-03-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NobelZygoma 45° is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2016-03-16 under 510(k) number K152093. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NobelZygoma 45°?

NobelZygoma 45° is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is Nobel Biocare AB. The 510(k) number is K152093.

When did NobelZygoma 45° receive FDA 510(k) clearance?

NobelZygoma 45° received FDA 510(k) clearance on 2016-03-16, under 510(k) number K152093.

Who is the listed applicant for NobelZygoma 45°?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NobelZygoma 45°?

The FDA product code for NobelZygoma 45° is DZE.

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Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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